It can be very confusing to determine whether your project meets the NIH definition of a clinical trial. Given the new Forms-E that will be effective starting with January submission deadlines, it is now more important than ever to correctly characterize your project.
NIH has provided investigators with a useful tool in order to make this determination. This series of questions will help you to ascertain whether your proposed project meets the NIH definition of a clinical trial, which will help to guide you as you complete all of the newly required Human Subjects attachments.
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